Phase I Study of Nimotuzumab in Solid Tumours

Summary

This is a phase I trial of nimotuzumab that will be conducted in patients with advanced
incurable solid tumors. This is a dose-seeking study to determine the maximum tolerated and
recommended phase II doses of nimotuzumab that can be safely given to patients with advanced
and/or metastatic solid tumors.

Description

This is an open-label, dose-escalating, phase I trial of nimotuzumab in patients with
advanced incurable solid tumors. The objective of this study is to determine the maximum
tolerated dose (MTD) and the recommended phase II dose (RP2D) of nimotuzumab that can be
given in a weekly schedule in patients with advanced and/or metastatic solid tumor cancer.
This study will also examine the safety, pharmacodynamics and preliminary efficacy of
nimotuzumab in this patient population.

This study was conducted to evaluate the efficacy and safety of nimotuzumab combined with chemotherapy as first-line therapy in advanced lung squamous cell carcinoma (LSCC), and to explore predictive ...

Adolescent and young adult (AYA) patients with advanced solid tumours are often considered for phase I clinical trials with novel agents. The outcome of AYAs in these trials have not been described be...

Larotrectinib (VITRAKVI) is an orally administered, small molecule, highly-selective, tropomyosin receptor kinase (TRK) inhibitor that was developed by Loxo Oncology in collaboration with Bayer AG as ...

Pyrotinib is an irreversible dual pan-ErbB receptor tyrosine kinase inhibitor developed for the treatment of HER2-positive advanced solid tumours. Based on positive results in a phase II trial, the d...

nab-Paclitaxel has demonstrated efficacy in adults with solid tumours and preclinical activity in paediatric solid tumour models. Results from phase I of a phase I/II study in paediatric patients with...

Medical and Biotech [MESH] Definitions

Krukenberg Tumor

Mucocellular carcinoma of the ovary, usually metastatic from the gastrointestinal tract, characterized by areas of mucoid degeneration and the presence of signet-ring-like cells. It accounts for 30%-40% of metastatic cancers to the ovaries and possibly 1%-2% of all malignant ovarian tumors. The lesions may not be discovered until the primary disease is advanced, and most patients die of their disease within a year. In some cases, a primary tumor is not found. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1685)

Technology, High-cost

Advanced technology that is costly, requires highly skilled personnel, and is unique in its particular application. Includes innovative, specialized medical/surgical procedures as well as advanced diagnostic and therapeutic equipment.

Solid Waste

Garbage, refuse, or sludge, or other discarded materials from a wastewater treatment plant, water supply treatment plant, and air pollution control facility that include solid, semi-solid, or contained material. It does not include materials dissolved in domestic sewage, irrigation return flows, or industrial discharges.

Chromatography, Gas

Fractionation of a vaporized sample as a consequence of partition between a mobile gaseous phase and a stationary phase held in a column. Two types are gas-solid chromatography, where the fixed phase is a solid, and gas-liquid, in which the stationary phase is a nonvolatile liquid supported on an inert solid matrix.

Advanced Cardiac Life Support

The use of sophisticated methods and equipment to treat cardiopulmonary arrest. Advanced Cardiac Life Support (ACLS) includes the use of specialized equipment to maintain the airway, early defibrillation and pharmacological therapy.

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